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Comments to HHS on Regulatory Burdens

In January of 2002, the Department of Health and Human Services requested public comment to it's newly-created Secretary's Advisory Committee on Regulatory Reform. Commenters were asked to identify regulatory burdens in health care delivery, health care operations, development of drugs and other medical products and biomedical and health services research. HHS also asked for recommendations of less burdensome alternatives to achieve the same goals.

In response, we filed five comments on the following topics (WORD docs):
1. The need for an expedited process for correcting false and erroneous postings in the Health Integrity and Protections Data bank (HIPDB)
2. A carrier's accusation of health care fraud to a provider must require evidence of willful, knowing and intentional acts
3. Medicare payments wrongly made due to carrier error should be the carrier's liability
4. Providers should be permitted to prescribe therapies that are approved as safe and effective in other countries
5. Medicare Part B carriers should be required to publish a single definitive list of covered services and be limited to implementing coverage changes on a quarterly basis

The following Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice were approved by the Federation of State Medical Boards at their San Diego conference. We expect that if state medical boards implement these guidelines, they will be sued. The comments were presented to the Federation on Friday, April 26 2002, by attorney Jonathan Emord on behalf of AAHF, in an effort to convince the Federation not to approve the Guidelines as submitted. Many others in attendance also spoke in opposition to the proposal, to no avail.

In addition, AAHF filed these comments (Word doc) on an earlier version of FSMB's guidelines. While some of our suggestions were incorporated in the latest version of their guidelines, many of our major objections still hold and we still have many concerns about the direction the Federation is heading.

In response to the Federation's approval of the Guidelines, we have sent our comments to every state medical board and medical society in the United States, alerting them to the fact that the Guidelines could affect every physician using any therapy considered innovative, not only those they would expect to be affected: those using so-called complementary and alternative medicine (CAM).

A major flaw in the Guidelines is the attempt to subdivide medical practice into CAM and conventional practice groups, violating state licensing statutes in which medicine is broadly defined to include any method of treatment of human ailment, disease, pain, injury, deformity, mental or physical condition. After artificially dividing physicians into two camps, the FSMB then holds one category to a different standard, for example, prohibiting the sale, rental or lease of health-related products by CAM physicians.

The battle continues. In an effort to press the U.S. Food and Drug Administration to implement the Pearson decision, AAHF joined in filing health claims for saw palmetto, folic acid, Omega 3 fatty acids, fiber, Vitamin E and Vitamin B. The agency initially denied four of the claims, and refused to allow the use of disclaimers in every instance, so we pursued them as outlined below. It is important to keep in mind that, in spite of the Appeals Court decision, the agency has not yet defined the "significant scientific agreement" standard which was ruled unconstitutional and which was nevertheless used to review these claims. Our win/loss record to date is as follows:

WON: Folic acid supplementation (.8mg) is more effective than a lesser amount, and more effective than from foods in common form in preventing neural tube defects. While the agency would not approve a claim or a disclaimer for .8 mg, it did write four claims of its own for .4 mg of folic acid. We felt the agency ignored valid scientific evidence and mislead women with its claims, so we again filed suit against the agency, along with Durk Pearson, Sandy Shaw, Dr. Julian Whitaker, Pure Encapsulations, Inc., and XCEL Medical Pharmacy, Ltd. We also filed an injunction preventing the agency from prohibiting use of our claim until a decision was reached on the merits of the lawsuit.

On February 1, 2001, U.S. District Court Judge Gladys Kessler partially granted the motion for a preliminary injunction and ordered the agency to consider one or more disclaimers, saying "It is clear that the FDA simply failed to comply with the constitutional guidelines outlined in Pearson. Indeed the agency appears to have at best misunderstood, and at worst, deliberately ignored, highly relevant portions of the Court of Appeals opinion. Even a cursory examination of the scientific literature on which the FDA relied…demonstrates that the FDA's conclusion that the 'weight' of the evidence was against plaintiffs' folic acid claim was arbitrary, capricious and an abuse of discretion." On April 3, 2001, the agency conceded defeat and authorized a health claim with a disclaimer for .8 mg of folic acid. For more detail, visit our attorney's web site at www.emord.com, and www.emord.com/folicacidcomplaint.doc.

LOST: Vitamin E supplements and heart disease: the agency insisted that there is no significant scientific agreement, and that until a rulemaking to reconsider the general health claims regulations for supplements is complete, FDA intends to deny, without prejudice any claims that fail to meet that undefined standard; nor is it authorizing the use of disclaimers until that time.

LOST: Fiber and colorectal cancer: the agency denied the claim, citing lack of significant, scientific agreement, and denied the proposed disclaimer saying "The weight of the evidence for a health claim about dietary fiber and colorectal cancer is outweighed by the evidence against such a claim. Therefore, FDA has determined that health claims relating dietary fiber and reduced risk of colorectal cancer are inherently misleading and cannot be made non-misleading with a disclaimer or other qualifying language."

WON: B Vitamins and vascular disease: After the agency rejected our initial claim, we joined Dr. Julian Whitaker, Durk Pearson, Sandy Shaw and Pure Encapsulations, Inc. in yet another lawsuit against the FDA. We also filed an application for preliminary injunction and were prepared to file two motions for summary judgment against the FDA Commissioner and the Director of the Center for Food Safety and Applied Nutrition, compelling them to comply immediately with the disclaimer requirement set forth in Pearson v. Shalala. On March 27, 2001, shortly before the agency had to respond to the preliminary injunction, it announced that it had changed its position and would permit use of the health claim we had originally filed, with the disclaimers we said we would accept. Effective immediately, the government agreed to allow the use of our health claim on all products that contain the combination of Vitamin B6, B12 and folic acid, stating that, as part of a well-balanced diet low in saturated fat and cholesterol, the supplements may reduce the risk of vascular disease. For more detail, visit www.emord.com/COMPLAINT_SAWPALMETTO.doc

WON: Omega-3 Fatty Acid: While the agency did not approve our health claim, it did approve a lengthy one of its own crafting, making the connection between Omega-3 fatty acid and the reduction of coronary heart disease. While we believe that the agency's version is unnecessarily wordy and negative, we decided not to challenge it. The FDA decision is available on line at www.fda.gov.

UNDECIDED: The claim regarding saw palmetto and BPH is still under review by the agency, but initial responses seem to suggest that the claim will be considered a drug claim, not a health claim, and therefore denied. To date, the agency has been unable to complete its review of the antioxidant claim, saying that its work is complicated by the large number of new human studies that were conducted since FDA's original 1991-1993 review. "Further," the agency wrote, "the review has been complicated by the fact that the proposed claim addresses relationships between antioxidant vitamins and a number of different types of cancers. Each of these multiple relationships needs to be evaluated individually." www.emord.com/COMPLAINT_SAWPALMETTO.doc

Lieberman v. American Dietetic Association

AAHF supported Shari Lieberman, Ph.D., a well-respected nutritionist and AAHF Board Member, in her successful lawsuit against the American Dietetic Association, which suspended her registered dietitian credential solely because of views she expressed in her magazine columns. Dr. Lieberman was successful in forcing the ADA to reinstate her RD credential and in forcing the ADA to publicly acknowledge its mistake with retractions and notices to its membership.

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